Instrumentation Laboratory recalls

All Instrumentation Laboratory recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (32).

32 recalls published between February 5, 2025 and August 12, 2026. Most common issues: microbial contamination (1).

• GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504… recall
  FDA August 12, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510… recall
  FDA August 12, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 Product Name: GEM Premier 5000 Model recall
  FDA August 5, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 Product Name: GEM Premier 5000 Model recall
  FDA August 5, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 Product Name: GEM Premier 5000 Model recall
  FDA August 5, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 Product Name: GEM Premier 5000 Model recall
  FDA August 5, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Model recall
  FDA August 5, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 with IQM2 Model recall
  FDA August 5, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• GEM Premier 5000 PAK, Part No recall
  FDA March 18, 2026 · Instrumentation Laboratory · Class II
• The product is used for the evaluation of the intrinsic coagulation… recall
  FDA January 21, 2026 · Instrumentation Laboratory · Class II
• HemosIL SynthAFax recall
  FDA December 24, 2025 · Instrumentation Laboratory · Class III
• HemosIL LMW Heparin Controls recall
  FDA August 20, 2025 · Instrumentation Laboratory · Class II
• HemosIL Heparin Calibrators recall
  FDA February 5, 2025 · Instrumentation Laboratory · Class II